Sr. Manager/Associate Director, Clinical Supply Chain – FibroGen, Inc. – San Francisco, CA, USA
FibroGen seeks a Clinical Supply Chain professional at the Sr. Manager or Associate Director level. The successful incumbent will ensure that all clinical trials have timely and adequate supply for administration to subjects. The Clinical Supply Chain group is involved in a clinical trial from the early stages of inception to study closure. This role includes demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, inventory management at depots and sites, order management and proof of delivery, and return or destruction. Additionally the manager implements and ensures group compliance to procedures for the production and distribution of investigation product.
Responsibilities include but are not limited to:
- Interpretation of a protocol or study overview to calculate total demand and translation of total
demand into a demand forecast over time Managing clinical labeling including label design and
manufacturing. - Preparation of a supply plan to support the demand forecast, including determination of supply
overage amounts. - Importing and exporting clinical trial material.
- Manage clinical packaging/distribution including negotiating contracts, designing clinical supply
plans and developing the distribution instructions with clinical supply chain vendors. - Setting up Integrated Voice and Web Response Systems with the clinical team.
- Interfacing between the CMC and clinical teams.
Job Qualifications :
- BS/BA degree.
- Minimum 5+ years industry experience in clinical operations or supply chain management. Title
- will be based on experience.
- Experience with clinical blinding practices.
- Experience setting up Integrated Voice and Web Response Systems.
- Working knowledge of drug development process (Phase I-IV).
- Working knowledge of cGMPs.
- Experience with clinical labeling, packaging and distribution including cold chain, importing and
exporting. - Strong analytical and problem solving skills.
- Ability to handle multiple projects simultaneously.
- Proven project management skills.
- Team player with demonstrated strong interpersonal skills and ability to build effective working
relationships throughout all levels of the organization. - Use of Microsoft Office including Word, Excel, PowerPoint, Visio and Microsoft Project.
